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| |  Long-Term Study Suggests Patients on a New Anti-Hypertensive May Fare Better Than Those on Most Widely-Prescribed Treatment Lercanidipine Acts in a Unique Way to Lower Blood Pressure While Offering Fewer Side Effects NEW YORK, NY -- November 11, 2002 -- Forest Laboratories, Inc. (NYSE: FRX) announced that findings from a multi-center, randomized study published this month in the American Journal of Hypertension show that lercanidipine, an investigational drug for the treatment of hypertension, was significantly better tolerated than amlodipine (Norvasc®), the most commonly-prescribed calcium channel blocker, allowing substantially more patients to remain on treatment. Lercanidipine is a next-generation dihydropyridine (DHP) calcium antagonist currently under review by the U.S. Food & Drug Administration (FDA). The study authors of the COHORT trial reported that 3 times less patients withdrew from the trial due to edema (leg and ankle swelling) when treated with lercanidipine in comparison with those on amlodipine (2.1% vs. 8.5%, p=<0.001). The results suggest lercanidipine may help address a persistent problem with an otherwise highly effective class of anti-hypertensive medication -- namely edema, a bothersome side effect that may often cause patients to discontinue treatment. In addition, the incidence of edema in patients treated with lercanidipine was more than 50 percent lower than in those taking amlodipine (8.3% vs. 18.5%, p=<0.001). Edema is among the most commonly reported side effects of calcium antagonist therapy.(1) Researchers believe that lercanidipine's novel chemical structure that allows the molecule to be held in the membrane in order to block the calcium channel receptor in a gradual and constant fashion may explain its steady reduction in blood pressure and overall low incidence of side effects. "This is the first meaningful advance in calcium channel blockers in six years," said Franz Messerli, MD, of the Ochsner Clinic Foundation and Clinical Professor of Medicine, Tulane University School of Medicine, New Orleans. "The results are exciting because they suggest lercanidipine, even at the highest dose, is a well tolerated medication patients can maintain long-term, helping to ensure adequate control of their hypertension." Untreated or hypertension, often a symptomless disease, poses a serious public health threat, often resulting in stroke, heart attack, or other serious complications. COHORT was a double-blind, parallel-group study of 828 people, age 60 or older, with hypertension. The study was designed to evaluate the tolerability of lercanidipine and a similar agent, lacidipine, with that of amlodipine. Patients were assigned to receive lercanidipine 10-20 mg, amlodipine 5-10 mg, or lacidipine 2-4 mg, and were treated for up to 24 months. All treatments were used as a single agent, or as the starting agent in combination with other anti-hypertensive medications. The COHORT results demonstrate that, while all patients showed a comparable level of blood pressure control, patients taking the next- generation CCBs lercanidipine and lacidipine, reported significantly fewer edema-related symptoms than amlodipine at the six-month mark (8.3%, 4.3% and 18.5%, respectively). The incidence of other side effects, including flushing, headache, dizziness, vertigo, asthenia (loss of strength), palpitations (irregular heart beat), and tachycardia (rapid heartbeat), did not differ among the treatments. About Hypertension About Lercanidipine About Forest Laboratories * Benicar is a licensed trademark of Sankyo Pharma. (1) Conlin PR, Williams GH. Use of Calcium Channel Blockers in Hypertension. Advances in Internal Medicine. 1998; 43: 533-562.
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